Clinical Trial: ACCEL-LOADING-ACS Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome

Brief Summary: The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary intervention (PCI).

Detailed Summary: In ACS patients, platelet activation, inflammation, and ischemia-reperfusion injury can be closely associated with the risk of post-PCI myonecrosis and ischemic events occurrence. In the ACCEL-AMI (Adjunctive Cilostazol versus high maintenance-dose ClopidogrEL in patients with Acute Myocardial Infarction)study, adjunctive cilostazol increased platelet inhibition compared with double-dose clopidogrel. Meanwhile, statins can reduce the extent of myonecrosis via limiting inflammation and myocardial infarct size by activating phosphatidylinositol-3-kinase (PI3K), ecto-5'-nucleotidase, Akt/endothelial nitric oxide synthase (eNOS), and the downstream effectors inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). Inhibition of PI3K, adenosine receptors, eNOS, iNOS, or COX-2 abrogates the protective effects of statins. In animal study, the combination of low-dose statin with cilostazol synergistically limits infarct size. Multiple studies have shown that cilostazol can influence inflammation and RISK pathway using the similar pathway with statin. This study will be performed to evaluate the role of adjunctive cilostazol in platelet inhibition, inflammation, and myonecrosis compared with standard treatment.
Sponsor: Gyeongsang National University Hospital

Current Primary Outcome: Major adverse cardiovascular events (MACE) [ Time Frame: 1 month ]

Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • P2Y12 reaction unit levels in the 2 arms [ Time Frame: 1 month ]
  • MACE incidence according to P2Y12 reaction unit [ Time Frame: 1 month ]
  • any post-procedural increase of markers of myocardial injury above ULN [ Time Frame: 1 month ]
  • post-procedural variations from baseline of hs-CRP levels in the 2 arms [ Time Frame: 1 month ]
  • ACUITY major/minor bleeding rate [ Time Frame: 1 month ]
  • 24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin) [ Time Frame: 1 month ]


Original Secondary Outcome: Same as current

Information By: Gyeongsang National University Hospital

Dates:
Date Received: May 15, 2011
Date Started: July 2010
Date Completion:
Last Updated: September 23, 2013
Last Verified: September 2013